Osteopathic Manipulative Treatment Efficacy in Postoperative Pain

Pain Clinical Trial

Official title:

Osteopathic Manipulative Treatment Efficacy in Sternal Pain Management After Heart Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02694991
• Other study ID #: 0001-2013
• Status: Completed
• Phase: Phase 4
• First received: February 19, 2016
• Last updated: February 29, 2016
• Start date: September 2013
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Effectively controlling sternal pain during cardiac rehabilitation after heart surgery is very important as it reduces the risk of postoperative complications.

However, the contraindications and side effects of analgesic drugs may induce physicians to use them so cautiously that pain may actually be under-treated.

The aim of this open label, controlled study is to assess whether osteopathic manipulative treatment (OMT) can contribute to pain relief and improve rehabilitation outcomes.

Description:

The currently predominant means of controlling postoperative pain is the peri-operative administration of opioid or non-opioid (acetaminophen) analgesics, alone or in combination, and non-steroidal anti-inflammatory drugs (NSAIDs). However, anti-inflammatory drugs are contraindicated for many patients because they may impair renal function, interact with platelet aggregation, and increase the risk of gastrointestinal damage and bleeding. The spectrum of available options is narrow.

Osteopathic manipulative Treatment (OMT) intervenes in the process that transforms nociceptive information into the subjective experience and it may be useful.

It has been found to be effective in controlling pain after abdominal surgery, it has a beneficial effect on patients recovering coronary artery by-pass surgery and also improves cardiac function The aim of this study was to assess whether complementary OMT is an effective means of reducing post-surgical sternal pain and improving rib cage mobility after heart surgery involving sternotomy, and to investigate its advantages during in-patient rehabilitation in terms of functional recovery, and perceived anxiety and depression.

This open, randomised, semi-blinded, controlled trial involves inclusion of 80 adult patients of both genders consecutively admitted as in-patients to cardiac rehabilitation unit after undergoing elective coronary artery by-pass grafting (CABG), valve replacement or repair and/or ascending aorta surgery with sternotomy, and capable of voluntarily providing their written informed consent. The patients are divided in 2 groups, the intervention group receiving OMT and the control group. Both groups are following the same rehabilitation programme and receiving usual care.

All of the subjects taking part in the study are receiving standard care in accordance with the international guidelines for in-patient cardiac rehabilitation; the only experimental intervention is the addition of OMT

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Recent artery bypass grafting (CABG)

• Recent valve replacement or repair

• Recent ascending aorta surgery

Exclusion Criteria:

• Heart surgery using mini-thoracotomy.

• Heart transplantation

• Implant of a ventricular assistance device

• Diabetes mellitus

• Rheumatoid arthritis

• Autoimmune diseases

• Altered cognitive capacities

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Surgery

Intervention

Other:
• Osteopathic Manipulative Treatment
The thoracic wall is gently manipulated in conscious subjects in a supine position in order to facilitate greater diaphragmatic excursion. The thorax is palpated by applying a low pressure load directly on the skin in the direction of resistance, without any sliding over the skin or forcing of the subcutaneous tissue until it begins to yield and there is a sensation of softening. Sterile procedures are used when touching the patients near the surgical site. The treatment consists of a fixed and preordained sequence of three sessions, beginning with the costal arch on the diaphragm and then moving to the sternal area and, finally, the region of the thoracic outlet. The first two phases are performed from the right side, and the third from the head of the bed.

Locations

Country	Name	City	State
Italy	Fondazione Don C. Gnocchi ; Istituto S. Maria Nascente IRCCS	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity relief	Pain intensity measured with visual analogic scale (VAS)	21 days	No
Secondary	Functional capacity improvement	Distance in meters walked in six minutes	21 days	No
Secondary	Respiratory function	Inspiratory volume variation measured as mL of air inspired	21 days	No
Secondary	Hospitalization length	Number of days of hospitalisation	21 days	No
Secondary	Anxiety and Depression	Hospital Anxiety and Depression Scale (HADS) score	21 days	No
Secondary	Analgesic drug consumption.	Number of analgesic drug doses taken	21 days	No